Process Development

At PCT, though multidisciplinary teams, we offer process design, optimization and scale-out/scale-up services to bring you value throughout each stage of clinical development. Even if your product has never been used in the clinic, we can leverage our expertise to efficiently take your process to the next level. Our ultimate goal is to help you create a manufacturing process specific to your needs that will prioritize quality, cost of goods and sustainability, resulting in a commercially viable product.

Our process development services include:

  • Optimization of input materials and unit processes
  • Closed processing and automation
  • Improvement of process efficiency
  • Process and product characterization and validation
  • GTP/cGMP documentation and batch record development
  • Product comparability and stability studies
  • Product storage, cryopreservation and transportation optimization
 
Ines Mende, PhD, Associate Director, Process Development, Mountain View
PhD (Immumology), Technical University, Munich, Germany
 

Ines is an experienced immunologist with 15 years of hands-on research experience in the biotech industry and at academic institutions. At PCT provides subject matter expert support for client clinical trials and leverages her expertise in tech transfer, process development, assay development, flow cytometry, immune cell characterization, cell culture and isolation of rare cell populations from human blood and tissues.

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Together, PCT’s process and analytical development services, combined with our Center for Innovation & Engineering, ensure that our cell therapy clients will have a manufacturing process that is optimized to deliver products in a reasonable timeframe, in a scalable, sustainable way that meets all applicable regulatory requirements.

In addition to analytical development, we also offer process development services.

LEARN ABOUT ANALYTICAL DEVELOPMENT

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